Diabetes MellitusNCT03970161
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
A study testing routine ophthalmic examination in people with Diabetes Mellitus and Diabetic Retinopathy, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
- What is being tested?
- routine ophthalmic examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with T2DM
- Patients without microangioma
Who cannot join
- Patients with any other ocular disease that might affect retinal nerve injury
- Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
- Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
- Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Xiang Zhu, Doctor, 13826452564, 0628zhuxiang@163.com
About this study
The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.
Read the detailed description
Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
- Being tested
- routine ophthalmic examination
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine ophthalmic examinationDevice
Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination. Patients with DM also underwent fundus fluorescein angiography (FFA) examination.
| Study group | Role | What they receive |
|---|---|---|
| T2DM Patients | Experimental | Patients without microangioma changes undergoing FFA examination were included in the present study. All of the participants enrolled in the present study underwent a systematic ophthalmic examination. Receives: Device: routine ophthalmic examination |
| healthy control subjects | Experimental | All of the participants enrolled in the present study underwent a systematic ophthalmic examination. Receives: Device: routine ophthalmic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripapillary RNFL thickness
Peripapillary RNFL thickness
Measured: 96 weeks
GCL+ in the macular area obtained using the 3D wide mode
GCL+ in the macular area obtained using the 3D wide mode
Measured: 96 weeks
Retinal thickness in all macular regions
Retinal thickness in all macular regions
Measured: 96 weeks
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Measured: 96 weeks
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start29 May 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiang Zhu, Dorctor, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970161
- Sponsor's protocol ID
- Retinal nerve injury in T2DM
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03970161
- Acronym / sponsor ID
- Retinal nerve injury in T2DM
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Nerve Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.
Detailed description
Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM Patients | Experimental | Device: routine ophthalmic examinationPatients without microangioma changes undergoing FFA examination were included in the present study. All of the participants enrolled in the present study underwent a systematic ophthalmic examination. |
| healthy control subjects | Experimental | Device: routine ophthalmic examinationAll of the participants enrolled in the present study underwent a systematic ophthalmic examination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with T2DM
- Patients without microangioma
Key exclusion criteria (4 listed)
- Patients with any other ocular disease that might affect retinal nerve injury
- Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
- Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
- Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine ophthalmic examinationRoutine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination. Patients with DM also underwent fundus fluorescein angiography (FFA) examination. | Device | T2DM Patients, healthy control subjects |
Primary outcome
Peripapillary RNFL thickness
Time frame: 96 weeks
Peripapillary RNFL thickness
GCL+ in the macular area obtained using the 3D wide mode
Time frame: 96 weeks
GCL+ in the macular area obtained using the 3D wide mode
Retinal thickness in all macular regions
Time frame: 96 weeks
Retinal thickness in all macular regions
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Time frame: 96 weeks
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Time frame: 96 weeks
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Zhu, Dorctor principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine ophthalmic examination in people with Diabetes Mellitus and Diabetic Retinopathy, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Zhu (13826452564, 0628zhuxiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripapillary RNFL thickness (time frame: 96 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.